The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Procedure: Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia

• Registration Number: NCT04156334
• Lead Sponsor: University of Ljubljana

Brief Summary

Use of local anaesthesia during full mouth dental rehabilitation under general anaesthesia is an everyday practice. It enables better control of the post-extraction bleeding and better control of physiological responses. Postoperative numbness and lip and cheek biting can be an undesired side effect. With our research, we aim to compare two different types of local anaesthesia in relation to postoperative side effects. We also aim to assess the oral health-related quality of life after treatment in general anaesthesia to enlighten how full mouth rehabilitation affects a child's life.

Detailed Description

Dental treatment of children under general anaesthesia (GA) is intended for children who, for one reason or another, are unable to participate in the outpatient clinic.

When extracting teeth in GA, local anaesthetics (LA) are regularly applied to control bleeding, reduce postoperative sensitivity, and to better control vital functions. The side effects of LA can be the patient's irritation due to not understanding the postoperative numbness and lip and cheek biting.

The aim of our study is to determine if there is a difference between the two types of local anaesthesia (computer-controlled intraosseous anaesthesia and classical local/conductive anaesthesia) in the frequency and extent of the occurrence of side effects postoperatively.

The research data would help establish a better dental extraction protocol for children under GA, which would allow for less postoperative complications.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-02-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Paediatric patients intended for dental treatment in general anaesthesia

Exclusion Criteria

• Patients who can not express feelings adequately,
• patients where there will not be any teeth extracted,
• patients whose parents do not want to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
computer-controlled intraosseous anaesthesia	Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia	Patients will receive the local anaesthetic using computer-controlled intraosseous anaesthesia (Quicksleeper 5) before the tooth extraction in general anaesthesia.
infiltrative or conductive local anaesthesia	Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia	Patients will receive a local anaesthetic using carpule before the tooth extraction in general anaesthesia.

Primary Outcome Measures

Name	Time	Method
Pain scores before and over 48 hours after tooth extraction in general anaesthesia in the two study groups using The Children's Hospital of Eastern Ontario Pain over Scale (CHEOPS)	an average 51 hours (monitoring of pain will be performed one hour before the general anesthesia treatment, 2 hours after treatment, 12 hours after treatment, 24 and 48 hours after treatment	Monitoring's the pain with CHEOPS which evaluates crying, face expression, speech, body movement, touching of the painful area and leg movement. Each category has specific points according to the level of behaviour. Points are added and final scores range between 4-13 points. The number of scores at different measuring points before and over 48 hours after treatment will be compared between the two study groups.

Trial Locations

Locations (1)

University medical centre Ljubljana; 🇸🇮 Ljubljana, Slovenia